Prolastin

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Prolastin

DRUG DESCRIPTION

Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) is a sterile, stable,
lyophilized preparation of purified human Alpha1-Proteinase Inhibitor
(alpha1-PI), also known as alpha1-antitrypsin. Prolastin (alpha)
is intended for use in therapy of congenital alpha1-antitrypsin deficiency.

Prolastin (alpha) is prepared from pooled human plasma of normal donors by modification
and refinements of the cold ethanol method of Cohn.1 Part of the
fractionation may be performed by another licensed manufacturer. In order to
reduce the potential risk of transmission of infectious agents, Prolastin (alpha) has
been heat-treated in solution at 60±0.5°C for not less than 10 hours.
However, no procedure has been found to be totally effective in removing viral infectivity from plasma fractionation products. In vitrostudies designed
to evaluate the capacity of the Prolastin (alpha) manufacturing process to remove/inactivate
viruses have been conducted to provide additional assurance of the viral safety
profile as shown in the table below.

The specific activity of Prolastin is ≥ 0.35 mg functional alpha1-PI/mg
protein and when reconstituted as directed, the concentration of alpha1-PI
is ≥ 20 mg/mL. When reconstituted, Prolastin (alpha) has a pH of 6.6–7.4, a sodium
content of 100–210 mEq/L, a chloride content of 60–180 mEq/L, a sodium phosphate
content of 0.015–0.025 M, a polyethylene glycol content of not more than (NMT)
5 ppm, and NMT 0.1% sucrose. Prolastin (alpha) contains small amounts of other plasma
proteins including alpha2-plasmin inhibitor, alpha1- antichymotrypsin,
C1-esterase inhibitor, haptoglobin, antithrombinIII, alpha1-lipoprotein,
albumin, and IgA.1 Each vial of Prolastin (alpha) contains the labeled amount
of functionally active alpha1-PI in milligrams per vial (mg/vial),
as determined by capacity to neutralize porcine pancreatic elastase.1 Prolastin (alpha)
contains no preservative and must be administered by the intravenous route.

What are the possible side effects of alpha 1-proteinase inhibitor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

What are the precautions when taking alpha (Prolastin)?

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

What are the possible side effects of alpha 1-proteinase inhibitor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

What are the precautions when taking alpha (Prolastin)?

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

What are the possible side effects of alpha 1-proteinase inhibitor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

What are the precautions when taking alpha (Prolastin)?

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.